Diabetic Retinopathy Clinical Research Network Chair Grant

描述(由申请人提供)：本申请是为糖尿病视网膜病变临床研究网络(DRCR.net)网络主席延长五年的资金。DRCR.net致力于通过利用包括协调中心和网络主席办公室在内的专业基础设施资源的协作网络，支持糖尿病视网膜病变、黄斑水肿和相关疾病的多中心临床研究。该网络的主要目标是识别、创建、实施、分析和报告高质量的临床治疗方案，从而更好地了解糖尿病视网膜病变，推进其治疗，并改善糖尿病患者的生活。该网络的独特性及其规模效率允许使用来自NIH、行业和基金会的资金来执行协议。这些方案通常涉及不会由行业完成的试验，仅靠NIH的资金是不可行的。这些试验包括比较有效性研究，批准药物的新适应症，以及新疗法的测试，包括第一阶段和第二阶段临床试验。未来5年，DRCR.net的总体目标包括：1)继续以快速有效的方式开发方案，同时保持绝对的科学严密性和完整性；2)继续确定并集中即将进行的研究，关注当今最重要的医疗和公共卫生糖尿病眼科问题；3)继续采用创新的方法进行临床试验设计和实施、网络结构和教育。在下一个资金周期，该网络提议完成6-8个预计在资助期开始时正在进行的方案，启动10-15个新方案(包括每年1-2个新的主要方案)，治疗糖尿病视网膜病变、糖尿病黄斑水肿及相关疾病，通过征集新站点的参与来继续扩大DRCR.net，继续教育DRCR.net调查人员有关临床研究的原则，并指导选定的视网膜专家成为具体涉及糖尿病视网膜病变的临床试验的领导者。

DESCRIPTION (provided by applicant): This application is for a five-year extension of funding for the Diabetic Retinopathy Clinical Research Network (DRCR.net) Network Chair. The DRCR.net is dedicated to support multicenter clinical research of diabetic retinopathy, macular edema and associated conditions through a collaborative network utilizing specialized infrastructure resources that include a Coordination Center and Network Chair's office. The Network's primary goal is to identify, create, conduct, analyze and report high quality clinical tral protocols that lead to a better understanding of diabetic retinopathy, advance its treatment, and improve the lives of individuals with diabetes. The uniqueness of the Network and its efficiencies of scale allow the performance of protocols using money from the NIH, industry, and foundations. These protocols often involve trials that would not be done by industry and would not be feasible with solely NIH funding. These trials include comparative effectiveness studies, new indications of approved drugs, and the testing of new therapies, including Phase I and II clinical trials. The general goals of the DRCR.net over the next 5 year period include 1) continuing to develop protocols in a rapid and efficient manner while maintaining absolute scientific rigor and integrity, 2) continuously identifying and focusing upcoming studies on the most important medical and public health diabetes ophthalmic issues of the day and 3) continuing the legacy of innovative novel approaches to clinical trial design & implementation, network structure, and education. During the next funding cycle, the Network proposes to complete 6-8 protocols that are expected to be in progress at the time the funding period begins, initiate 10-15 new protocols (including 1-2 new major protocols per year) in diabetic retinopathy, diabetic macular edema and associated conditions, continue to expand the DRCR.net by soliciting the participation of new sites, continue to educate the DRCR.net investigators on the principles of clinical research, and mentor selected retina specialists to be leaders in clinical trials with specific reference to diabetic retinopathy.